Clinical Investigation of the Cardioprotective Effect of Early Administration of SGLT2 in Patients Presented With AMI

Mohammad Hussien Tantawy Soliman

Status: Enrolling

Conditions: Myocardial Infarction

Treatments: Drug: Dapagliflozin 10mg Tab; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06009874

35541/6/22

Details and patient eligibility

About

This study aims to investigate the effect of early administration of DAPA during ischemia and before pPCI on infarct size, reperfusion injury-related myocardial damage, cardioprotection from HF, and renoprotection from AKI in patients with AMI.

Full description

DAPA was approved for HF patients, but there is no sufficient data about its efficacy on patients with AMI and if it can protect from the development of HF after AMI.

the investigators aim to investigate the effect of DAPA on patients who presented with AMI when administered as early as possible before pPCI and to be continued for three months after there.

the effect of DAPA on infarct size, cardiac biomarkers will be assessed during the follow-up period

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with ST-elevation myocardial infarction (STEMI).
2. STEMI was defined according to the Fourth Universal Definition of AMI.
3. 18 - 80 years of age.
4. Diabetics or non-diabetics.
5. eGFR > 45 ml/min/1.73m2.
6. Blood pressure before first drug dosing >110/70 mmHg.

Exclusion criteria

1. Cardiogenic shock.
2. Hypoglycemia.
3. History of diabetic ketoacidosis.
4. Genital and urinary infections.
5. History of AMI.
6. Stent thrombosis.
7. Previous coronary artery bypass surgery.
8. Severe hepatic insufficiency.
9. Advanced cancer patients.
10. Blood pH < 7.32.
11. Known allergy to SGLT-2 inhibitors.
12. Hemodynamic instability.
13. Females of childbearing potential without adequate contraceptive methods.
14. Patients currently on or have received any SGLT-2 inhibitors.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Dapagliflozin group

Active Comparator group

Description:

patients with MI will be treated with DAPA 10 mg once daily for three months.

Treatment:

Drug: Dapagliflozin 10mg Tab

Placebo group

Placebo Comparator group

Description:

patients with MI will be treated with a matching placebo once daily for three months.

Treatment:

Drug: Placebo